Intern - Regulatory Affairs

About the position Are you interested in learning new skills, exploring pharmaceutical research and manufacturing, networking with experts, and building a resume that opens doors? Join us to jumpstart your career! At Tolmar, you will connect with like-minded professionals in a supportive community. This is a place where you can make a meaningful impact and feel empowered by the abundant opportunities for growth. Tolmar, Inc. is a fully integrated pharmaceutical company based in Colorado. We develop, manufacture, and distribute both branded and generic prescription medications globally, focusing on oncology, urology, and pediatric endocrinology. Our long-acting injectables and oral medications offer innovative treatment options that meet the diverse needs of patients worldwide. By leveraging emerging technologies and developing new products, we aim to simplify treatment delivery and enhance the overall patient experience. About Regulatory Operations Regulatory Operations is a systems-based function within Regulatory Affairs that enables health authority submissions and ongoing regulatory compliance through standardized processes and operational excellence. The Regulatory Operations group is responsible for meeting submission technical requirements, managing Regulatory Information and monitoring global Regulatory Intelligence. Proposed Work Description The nature of business is that priorities can shift according to the needs of the company/department and therefore the work described below is a sampling of the kinds of work we expect this position to entail: A Regulatory Operations intern will gain hands‑on experience with the operational and technical aspects of regulatory submissions and regulatory systems. The internship provides exposure to eCTD submission workflows, regulatory information management practices, and regulatory intelligence processes, offering a practical understanding of how regulatory operations supports compliance and submission readiness in a regulated pharmaceutical environment.

Responsibilities

• Train with publishers and assist with document preparation by ensuring each document meets all FDA PDF Specifications.
• Work inside our Regulatory Information Management System, supporting Tolmar projects and products by maintaining Health Authority Correspondence and Submission Archives.
• Learn about our Regulatory Intelligence Program and how Tolmar uses an AI Platform (RegAsk) to monitor global intelligence. The intern will assist with initiatives to further widen the scope of these systems, assisting with data entry and creating processes and helping author best practices.

Requirements

• Ability to interact collaboratively and effectively in a team environment.
• Proficient computer skills and comfort with learning new systems and platforms.
• Strong attention to detail with the ability to follow established processes, technical instructions, and quality standards
• Awareness of regulatory submissions and electronic document standards (e.g., eCTD, PDF specifications) or willingness to learn technical regulatory requirements.
• Demonstrated experience in working with Microsoft Suite of programs (Word, Excel, PowerPoint, and Outlook) and Adobe.
• Ability to work independently when needed.
• Ability to manage and prioritize multiple projects and tasks demonstrating strong organization and time management skills; to work in a fast-paced environment.
• Pursuing a college degree in a scientific or technical field.
• Working conditions are normal for an office environment.
• Work is performed primarily remotely.
• The intern must have access to a private, quiet working area during business hours (8 AM-5 PM Mountain Time).

Benefits

• medical insurance
• 401k participation

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